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Roche’s implant for chronic eye disorder wins FDA approval

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Swiss drugmaker Roche Holding AG said on Friday the U.S. health regulator approved its eye implant for patients with a chronic disorder causing blurred vision, giving them an alternative to receiving monthly eye injections with existing treatments.

Roche’s Susvimo is a surgically implantable device intended to treat wet age-related macular degeneration (wet AMD), a disorder which occurs when abnormal blood vessels leak fluid or blood into an area near the retina called the macula.

The device is designed to continuously deliver a customized version of the company’s drug ranibizumab, branded as Lucentis, which is an anti-VEGF therapy.

Anti-vascular endothelial growth factor (anti-VEGF) therapies, the current standard of care for wet AMD, work against a protein said to play a key role in the disease and require patients to receive eye injections as often as monthly to preserve vision.

Susvimo, which is intended for those who have previously responded to at least two anti-VEGF injections, needs to be taken only twice a year.

More than 98% of patients treated with the device were able to go six months before needing a refill in the company’s late-stage study last year.

“This device will be a first-of-its-kind alternative to the current standard of care injections for patients with wet AMD,” Levi Garraway, Roche’s chief medical officer, said in an interview with Reuters before the approval.

The device has an exchange mechanism that simultaneously refills a new batch of medicine while the residual drug is removed, Garraway added.

UBS analyst Michael Leuchten estimates that the U.S. market size for AMD is roughly $3.5 billion.

Susvimo is also being reviewed for the treatment of wet AMD by the European Medicines Agency (EMA), the company said.

Lucentis was first approved for wet AMD in the United States in 2006. Other anti-VEGF therapies include Regeneron Pharmaceuticals’ Eylea and Novartis’ Beovu.

(Reporting by Amruta Khandekar and Bhanvi Satija; Editing by Aditya Soni and Maju Samuel)

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Biden presides over National Christmas Tree Lighting at start of holiday season

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U.S. President Joe Biden and his wife Jill participated in the National Christmas Tree Lighting Ceremony outside the White House on Thursday, helping to usher in the holiday season.

In a program that featured performances by singers Patti LaBelle, Billy Porter, and Kristin Chenoweth, the president presided over a countdown that ended with a brightly lit tree with a shining star on top.

Biden said the evergreen tree “reminds us that even in the coldest, darkest days of winter that life and abundance will return.”

The president, who unveiled hnew measures to fight the COVID-19 pandemic during the winter on Thursday, cited those who had lost loved ones to the deadly coronavirus and paid tribute to members of the military and their families.

“Jill and I are especially grateful to our service members and their families,” Biden said. “We also keep in our hearts those who lost loved ones because of this virus or any other cruel twist of fate or accident.”

The Bidens are spending their first holiday season in the White House as president and first lady. Earlier this week, holiday decorations were unveiled.

On Wednesday, Vice President Kamala Harris and her husband, Doug Emhoff, who is Jewish, celebrated Hanukkah with the lighting of a menorah at the White House.

 

(Reporting by Jeff Mason and Nandita Bose; editing by Grant McCool)

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CN aims to re-open crucial rail line in flood-hit province this weekend

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Canadian National Railway Co said on Wednesday that it was aiming to re-open its track in the crucial Kamloops-to-Vancouver corridor in the flood-hit province of British Columbia this weekend.

The Pacific province, trying to rebuild after devastating floods in November, received more rain over the weekend and this week.

CN operates one of the two critical rail lines in British Columbia that were forced to shut due to flooding and mudslides caused by heavy rains.

CN, which restarted limited service in the region last week, has now diverted some traffic from the corridor to the Port of Prince Rupert, while moving some of its trains on other available rail lines in the region, the company said in a statement.

Canadian Pacific Railway Ltd, the other main rail line operator, was also able to resume operations last week.

 

(Reporting by Ismail Shakil in Bengaluru and Rod Nickel in Winnipeg; Editing by Leslie Adler)

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British armed forces to allow people with HIV to enlist

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Britain plans to allow people who have tested positive for HIV to join the armed forces if they no longer carry a detectable amount of the virus, its defence ministry said on Wednesday.

Military personnel who become infected with HIV after enlistment can already remain in the armed forces – though they are classed as not fully fit, a categorisation which the defence ministry said it planned to change too.

“Drug treatment has revolutionised the lives and outcomes of people diagnosed with HIV. As a modern and inclusive employer, it is only right that we recognise and act on the latest scientific evidence,” junior defence minister Leo Docherty said.

The United States also currently bans people with HIV from joining its armed forces, and has faced legal challenge over its policy not to allow enlisted personnel who are HIV positive to commission as officers.

With the right treatment, the amount of virus in the blood of people infected with HIV can be reduced to undetectable levels, which in turn effectively eliminates the chances of them passing the virus which causes AIDS on to others.

From early next year, serving British military personnel who have tested positive for HIV, but no longer carry a detectable viral load, will be classed as fully fit, meaning they can be deployed on military operations.

People taking drugs that reduce the risk of contracting HIV will also be able to join the armed forces. Historically anyone taking regular medication has been unable to join Britain’s armed forces, with limited exceptions such as contraceptives.

The planned changes were welcomed by Britain’s National AIDS Trust. “A career in the armed forces was the only career not open to people living with HIV in the UK, and with this much-needed change the military will be more able to meet its obligation to promote inclusivity within its ranks,” said Deborah Gold, the trust’s chief executive.

 

(Reporting by David Milliken; Editing by Mark Heinrich)

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